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510(k) Data Aggregation

    K Number
    K070192
    Device Name
    ATRIUM PROLITE ULTRA S MESH
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2007-03-08

    (45 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ATRIUM PROLITE ULTRA S MESH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Atrium ProLite Ultra S Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for the Atrium Prolite Ultra S Mesh. This document is a regulatory communication from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

    It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies. These types of details would typically be found in the 510(k) submission summary or in a separate study report, which is not included in the provided text.

    Therefore, I cannot fulfill your request for that specific information based on the given input.

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